Sistas Inspiring Sistas Through Activity and Support

NCT02144571 | Completed

• 1 other identifier: Pro00008713
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

It is known that diet and physical affect a variety of disease-related endpoints and overall health status in general. The investigators also know that dietary and PA intervention effects are difficult for individuals to maintain. By contrast, the investigators have some evidence that group-based and family-centered, multi-component interventions are more effective in terms of creating large changes in diet-related outcomes. Using a group-randomized, controlled design, the overall goal of this project is to reduce breast cancer-related health disparities in a high-risk community, by achieving these Primary Aims,to conduct a regionally-based community-designed dietary and physical activity behavioral controlled trial among AA women,to test the effectiveness of the community-designed, family-based dietary and physical activity behavioral intervention on modifying biomarkers of inflammation and to test the effectiveness of the community-designed, family-based dietary and physical activity behavioral intervention on decreasing breast density

Conditions

Prevention Harmful Effects

Outcome Measures

Primary Outcomes (1)

• Inflammatory Response

  This will entail examining changes in the inflammatory index derived from dietary self-report and self-reported physical activity and blood samples.

  Baseline, 12 weeks and 12 months

Study Arms (2)

Lifestyle

EXPERIMENTAL

Diet and physical activity intervention group. Measurements taken at baseline, 12 weeks and 1 year.

Behavioral: Lifestyle

Wait-list control

NO INTERVENTION

No-treatment control group. Measurements taken at baseline, 12 weeks and 1 year. People in the control condition can elect to take the intervention after 1 year.

Interventions

Lifestyle BEHAVIORAL

Participants are consented and randomized into the intervention group or delayed intervention group(intervention offered one year later). Participants in intervention group attend 12 weekly sessions and 9 monthly sessions. All participants attend 3 clinics in which we collect data, measurements and blood samples. These clinics occur at baseline, 12 weeks and one year.

Also known as: SISTAS

Lifestyle

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• African American
• BMI 30 or\<
• Willing to be randomized,

You may not qualify if:

• History of cancer
• Inflammatory-related conditions
• Unstable hormones replacement treatment

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Study Officials

• Swann Arp-Adams, Ph.D

  University of South Carolina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jame Hebert

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 22, 2014
• Study Start: November 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)